Qualifications:
· Bachelor's degree or above in a relevant discipline required
· 5+ years of industrial experience in IVD or medical device FDA registration
· Proficiency in Chinese preferred
Tasks:
· Lead and support new product 510k Submissions
· Lead and support International Device Licensing and Registrations
· Support product development teams with new product submission requirements
· Provide guidance on worldwide regulatory requirements for medical devices and external government product audits by FDA and other inspection agencies as needed
· Lead and support the implementation of clinical research projects
· Develop and support clinical sites management through all phases of the clinical trial
· Travel to clinical sites during the qualification phase and as needed to ensure sites are in compliance and regulatory and study requirements are being fulfilled
· Ensure that documentation from clinical trial sites meets FDA/GCP/GDP requirements
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Experience level:
Experience:
- FDA regulations: 5 years (Preferred)
Ability to Commute:
- Bedford, MA 01730 (Required)
Ability to Relocate:
- Bedford, MA 01730: Relocate before starting work (Required)
Work Location: In person